Who is eligible for clinical trial NCT05804318?

Participants must meet protocol criteria for Prostate Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05804318 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-27

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer (NCT05804318)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Varian, a Siemens Healthineers Company

🩺 Plain-English Summary (8th-Grade Level)

This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (10 items).

Location: Duarte Cancer Center — Duarte, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
AUA/IPSS score is ≤ 15.
ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
Patient has the ability to complete required patient questionnaires.
Patient age ≥ 18 years (or greater than the local age of majority).
Patient has the ability to understand and the willingness to sign a written informed consent document.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patient has baseline grade ≥3 GI or GU toxicity
Patient has had prior overlapping pelvic radiotherapy.
Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
Patient has node positive prostate cancer.
Patient has extracapsular extension (capsular abutment is permitted).
Patient has active inflammatory bowel disease or active collagen vascular disease.
Patient cannot undergo prostate MRI.
Patient cannot undergo prostate fiducial marker placement.
Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

Duarte Cancer Center — Duarte, California
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California
Brigham and Women's Hospital — Boston, Massachusetts
Washington University in St. Louis — St Louis, Missouri
Fox Chase Cancer Center — Philadelphia, Pennsylvania
Klinikum der Landeshauptstadt Stuttgart gKAöR — Stuttgart, Baden-Wurttemberg
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) — Homburg, Saarland
Hospital Universitario de Navarra — Pamplona, Navarre

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗